6 resultados para Needs model
em DigitalCommons@The Texas Medical Center
Resumo:
Institutional Review Boards (IRBs) are the primary gatekeepers for the protection of ethical standards of federally regulated research on human subjects in this country. This paper focuses on what general, broad measures that may be instituted or enhanced to exemplify a "model IRB". This is done by examining the current regulatory standards of federally regulated IRBs, not private or commercial boards, and how many of those standards have been found either inadequate or not generally understood or followed. The analysis includes suggestions on how to bring about changes in order to make the IRB process more efficient, less subject to litigation, and create standardized educational protocols for members. The paper also considers how to include better oversight for multi-center research, increased centralization of IRBs, utilization of Data Safety Monitoring Boards when necessary, payment for research protocol review, voluntary accreditation, and the institution of evaluation/quality assurance programs. ^ This is a policy study utilizing secondary analysis of publicly available data. Therefore, the research for this paper focuses on scholarly medical/legal journals, web information from the Department of Health and Human Services, Federal Drug Administration, and the Office of the Inspector General, Accreditation Programs, law review articles, and current regulations applicable to the relevant portions of the paper. ^ Two issues are found to be consistently cited by the literature as major concerns. One is a need for basic, standardized educational requirements across all IRBs and its members, and secondly, much stricter and more informed management of continuing research. There is no federally regulated formal education system currently in place for IRB members, except for certain NIH-based trials. Also, IRBs are not keeping up with research once a study has begun, and although regulated to do so, it does not appear to be a great priority. This is the area most in danger of increased litigation. Other issues such as voluntary accreditation and outcomes evaluation are slowing gaining steam as the processes are becoming more available and more sought after, such as JCAHO accrediting of hospitals. ^ Adopting the principles discussed in this paper should promote better use of a local IRBs time, money, and expertise for protecting the vulnerable population in their care. Without further improvements to the system, there is concern that private and commercial IRBs will attempt to create a monopoly on much of the clinical research in the future as they are not as heavily regulated and can therefore offer companies quicker and more convenient reviews. IRBs need to consider the advantages of charging for their unique and important services as a cost of doing business. More importantly, there must be a minimum standard of education for all IRB members in the area of the ethical standards of human research and a greater emphasis placed on the follow-up of ongoing research as this is the most critical time for study participants and may soon lead to the largest area for litigation. Additionally, there should be a centralized IRB for multi-site trials or a study website with important information affecting the trial in real time. There needs to be development of standards and metrics to assess the performance of the IRBs for quality assurance and outcome evaluations. The boards should not be content to run the business of human subjects' research without determining how well that function is actually being carried out. It is important that federally regulated IRBs provide excellence in human research and promote those values most important to the public at large.^
Resumo:
The events of the 1990's and early 2000's demonstrated the need for effective planning and response to natural and man-made disasters. One of those potential natural disasters is pandemic flu. Once defined, the CDC stated that program, or plan, effectiveness is improved through the process of program evaluation. (Centers for Disease Control and Prevention, 1999) Program evaluation should be accomplished not only periodically, but in the course of routine administration of the program. (Centers for Disease Control and Prevention, 1999) Accomplishing this task for a "rare, but significant event" is challenging. (Herbold, John R., PhD., 2008) To address this challenge, the RAND Corporation (under contract to the CDC) developed the "Facilitated Look-Backs" approach that was tested and validated at the state level. (Aledort et al., 2006).^ Nevertheless, no comprehensive and generally applicable pandemic influenza program evaluation tool or model is readily found for use at the local public health department level. This project developed such a model based on the "Facilitated Look-Backs" approach developed by RAND Corporation. (Aledort et al., 2006) Modifications to the RAND model included stakeholder additions, inclusion of all six CDC program evaluation steps, and suggestions for incorporating pandemic flu response plans in seasonal flu management implementation. Feedback on the model was then obtained from three LPHD's—one rural, one suburban, and one urban. These recommendations were incorporated into the final model. Feedback from the sites also supported the assumption that this model promotes the effective and efficient evaluation of both pandemic flu and seasonal flu response by reducing redundant evaluations of pandemic flu plans, seasonal flu plans, and funding requirement accountability. Site feedback also demonstrated that the model is comprehensive and flexible, so it can be adapted and applied to different LPHD needs and settings. It also stimulates evaluation of the major issues associated with pandemic flu planning. ^ The next phase in evaluating this model should be to apply it in a program evaluation of one or more LPHD's seasonal flu response that incorporates pandemic flu response plans.^
Resumo:
This project involved developing a model for planning a dental emergency treatment center that could function as an embedded component of a shelter for the homeless population. The dental services provided by such a clinic should include treatment for tooth pain, dental caries or cavities, chipped or broken teeth, broken partials, abscessed teeth, emergency cleanings, periodontal disease or gum disease and fillings. These are the dental services that are most often sought by homeless people in hospital emergency rooms.^ The underlying assumption for this project was that the oral health needs of the homeless community can most effectively be addressed by implementing small dental clinics in existing facilities that provide shelter and other services for this population. The model described in this project identifies oral health care services that would be provided by the clinic, facility (physical plant) requirements and associated infrastructure to operate an embedded dental clinic, methods for obtaining funding, strategies of recruiting dental professionals to staff the facility, and methods to assess the outcomes of the embedded clinic strategy. As an example, this project describes a strategy for developing such an embedded clinic at San Antonio Metropolitan Ministries SAMM shelter based on recommendations from community health care leaders, managers of homeless shelters, members of the homeless community and dental professionals^
Resumo:
This paper will discuss the intersection of pill mills and the under-treatment of pain, while addressing the unintended consequence that cracking down on pill mills actually has on medical professionals' treatment of legitimate pain in clinical settings. Moreover, the impact each issue has on the spectrum of related policy, regulatory issues and legislation will be analyzed while addressing the national impact on medical care. Lastly, this paper will outline a process to develop a State Model Law on this subject. This process will include suggestions for the future and how we can move forward to adequately address public safety needs and how we can attempt to mitigate the unintended impact prescription drug trafficking has had on a patient's right to appropriate pain management. This balance is achievable and this paper will address ways we can find this elusive balancing point through the development of a State Model Law. ^
Resumo:
This study examines Hispanic levels of incorporation and access to health care. Applying the Aday and Andersen framework for the study of access, the study examined the relationship between two levels of Hispanic incorporation into U.S. society, i.e., mainstream versus ethnic, and potential and realized measures of access to health care. Data for the study were drawn from a 1992 telephone survey of 600 randomly selected Hispanics in Houston and Harris County.^ The hypotheses tested were: (1) Hispanics who are incorporated into mainstream society are more likely to have better potential and realized access to health care than those who are incorporated into ethnic-group enclaves regardless of their socioeconomic status (SES), health status and health needs, and (2) there is no interaction between the levels of incorporation (mainstream or ethnic) and SES, health status, and health needs in predicting potential and realized access.^ The data analysis supported Hypothesis One for the two measures of potential access. The results of bivariate and multiple logistic regression analyses indicated that for Hispanics in Houston and Harris County, being in the "mainstream" incorporation category increased their potential access to care, having "health insurance" and a "regular place of care". For the selected measure of realized access, having a "regular check-up", the analysis did not demonstrate statistically significant differences in having a regular check-up among Hispanics incorporated in the ethnic or mainstream incorporation categories.^ Hypothesis Two, that there is no interaction between the levels of incorporation and socioeconomic characteristics, health status, and health needs in predicting potential and realized access among Hispanics was supported by the data. The results of the logistic regression analysis showed that, after adjusting for socioeconomic status, health status, and health needs, the association between "level of incorporation" and the two measures of potential access ("health insurance" and having a "usual place of care") was not modified by the control variables nor by their interaction with level of incorporation. That is, the effect of incorporation on Hispanics' health insurance coverage, and having a usual place of care, was homogenous across Hispanics with different SES and health status.^ The main research implication of this dissertation is the employment of a theoretical framework for the assessment of cultural factors essential to research on migrating heterogeneous subpopulations. It also provided strategies to solve practical and methodological difficulties in the secondary analyses of data on these populations. ^
Resumo:
The problem of analyzing data with updated measurements in the time-dependent proportional hazards model arises frequently in practice. One available option is to reduce the number of intervals (or updated measurements) to be included in the Cox regression model. We empirically investigated the bias of the estimator of the time-dependent covariate while varying the effect of failure rate, sample size, true values of the parameters and the number of intervals. We also evaluated how often a time-dependent covariate needs to be collected and assessed the effect of sample size and failure rate on the power of testing a time-dependent effect.^ A time-dependent proportional hazards model with two binary covariates was considered. The time axis was partitioned into k intervals. The baseline hazard was assumed to be 1 so that the failure times were exponentially distributed in the ith interval. A type II censoring model was adopted to characterize the failure rate. The factors of interest were sample size (500, 1000), type II censoring with failure rates of 0.05, 0.10, and 0.20, and three values for each of the non-time-dependent and time-dependent covariates (1/4,1/2,3/4).^ The mean of the bias of the estimator of the coefficient of the time-dependent covariate decreased as sample size and number of intervals increased whereas the mean of the bias increased as failure rate and true values of the covariates increased. The mean of the bias of the estimator of the coefficient was smallest when all of the updated measurements were used in the model compared with two models that used selected measurements of the time-dependent covariate. For the model that included all the measurements, the coverage rates of the estimator of the coefficient of the time-dependent covariate was in most cases 90% or more except when the failure rate was high (0.20). The power associated with testing a time-dependent effect was highest when all of the measurements of the time-dependent covariate were used. An example from the Systolic Hypertension in the Elderly Program Cooperative Research Group is presented. ^